Baird: Yes. As the program grew, big pieces of what
I was doing were taken over by other people. For example, there is now
one person whose task it is to manage the laboratory and data entry. Every
week we are given a list of all the study participants and their laboratory
data. A computer programmer has designed a program to put in data from
several sources. We also have case managers now who see the patients in
the clinics. That was another part of my function. Then we have study
coordinators who run the studies for various research drugs. That was
another task I did. Then there is also recruitment. We have another person
who contacts the community information networks, decides [whether] to
advertise or not, and sends announcements to the newspapers. She and her
staff are another part of the group. What I was doing in my job has now
been expanded to a large group of about 35 to 40 people. It is very nice
to see the program grow to that extent.

As the program was expanded, it was also refined. Dr. Lane and Dr. Masur
remain the two physicians in charge, but now they have another level of
positions below them. These are the PI's [principal investigators] of
which there are eight. The top two in the organization are Dr. Lane and
Dr. Masur, and then, at the next level, are the attending physicians and
the principal investigators. They write all of the protocols in cooperation
with Dr. Lane and Dr. Masur. Half of the study coordinators work for NIAID
and the other half work for the Clinical Center under Critical Care Medicine.
The case managers work for the Nursing Department under the Clinical Center.
In addition, there are laboratory and data management people. It is a
quite a large organization.

Harden: In their roles as case managers, have nurses
moved into job classifications other than nursing?

Baird: No. The primary classification of the nurses
is nursing. At first I had many additional functions than just nursing.
My job title was a “health specialist.” This was a new role
for a nurse. Therefore the job description was new and for several years
it was only temporary. Then my position was later written to include more
nursing functions, and I became a “nursing specialist.” Each
time I was to be promoted, the job description had to be rewritten. When
I became a twelve [GS12] was the last time it was rewritten. I doubt if
it can be rewritten as a GS-13. All the study coordinators are at a GS-12
level. Since I am the study coordinator who has been here the longest,
I have a window in my office. The other study coordinators said that not
only was I the oldest but I had been here the longest, so they thought
that I should have the window office. There is some deference for age
and experience.

Rodrigues: This implies that you acquired this particular
office later. Initially was your office on the eleventh floor [of the
Clinical Center] or somewhere else?

Baird: Initially, I had a cart, and I pushed it around
from floor to floor. I had no office, no desk, nothing. I had no base
because there were no offices. Space was, and continues to be, a problem.
Dr. Masur told me that I could put my personal things in an office of
one of the anesthesiologists in the department who was away for six months.
I had patient files, test tubes, syringes, and other items on the cart.
When I was given some space, I kept the cart around just for sentimental
reasons. When I was using the cart, I would cover it over at the end of
the day so no one could see what was on it, and I would try to find a
corner somewhere to put it. I did not want people taking syringes and
so on. The cart would not fit in anyone's office.

For a couple of years I worked from my cart, and then I started sharing
offices. Critical Care Medicine is like a step child. It is not an institute,
so its space is very limited. For a long time, about a year or so, I shared
an office with someone on the fifth floor in the clinic, but this was
Neurology's clinic, so we knew it was just temporary. Then we were moved
to another office about eight feet by ten feet in size, with three people
in it. It was essentially a hallway, because people had to walk through
to get to their office. That was one of the worst situations. Then the
eleventh floor was organized to have clinical space, so we moved to the
eleventh floor. This clinic on the eighth floor [we are in now] was just
opened about three years ago. Actually, Dr. Lane, Vicky Davey, and Bill
Barrick designed what they wanted for the clinic. The case managers have
the largest rooms, since they see more patients and occasionally do a
physical assessment. The study coordinators have the smaller rooms since
we see fewer patients than the case managers. Our primary role is to manage
the whole study so we will do the initial assessment of the patients.
There are two doctors in the clinic. We have been based here for about
three years, and these have been the nicest surroundings that we have
had. We all have computers, and we have all sorts of support staff to
help us, too.

Harden: As a study coordinator, do you do only one study,
and another study coordinator manages a different study?

Baird: Usually. Sometimes we will manage two or three
studies at the same time. Right now I am managing two studies. One of
them is moving quickly and one of them is moving rather slowly.

Harden: What are they on?

Baird: One
of them is evaluating a drug for toxoplasmosis. The drug is 566 C80, or
Mepron, and it was approved by the FDA [Food and Drug Administration]
last September [1992]. It had already gained approval for treatment of
Pneumocystis pneumonia, although it treats both infections. It
is an anti-protozoal agent, so it is effective both against Pneumocystis
pneumonia and toxoplasmosis. It was approved for treatment of Pneumocystis
pneumonia, but we know that physicians in the community are probably writing
prescriptions for it for toxoplasmosis. The Burroughs Wellcome Company,
which is the drug company that makes it, decided to close those studies
and gather any other data in another fashion.

I am continuing to manage that study. There is just one person on it
and he is still doing well. He comes in every three months, and when he
comes in, he sees the case manager. For the months he does not come in,
she calls his doctor and gets the information faxed to us. We keep track
of the patient on a monthly basis, even though he only comes here [to
the NIH] once every three months.

The other study is on a new drug called HPMPC. This is made by Gilead
Pharmaceuticals, which is a new, very small drug company in San Francisco.
This drug has activity against CMV [cytomegalovirus]. We started this
study in September [1992]. We are now fifteen patients into the study.
Tomorrow I will screen the sixteenth patient. The study is for sixteen
patients. The drug has shown some good effect against the virus. It has
some toxicities that we are trying to control. We have had several amendments
and changes to the protocol as the study proceeded.

A few years ago, in 1985, I worked on the ganciclovir study, and that
drug finally was approved by the FDA for the treatment of CMV retinitis.
Then, in 1989, I managed the foscarnet study. The data from the studies
at the NIH was very influential in obtaining FDA approval. I have been
fortunate to be involved in studies of a number of drugs that have received
FDA approval. It is a nice reward, after the hard work of gathering the
data and getting it organized, that ultimately, there are millions of
people getting this drug that would not ordinarily have done so because
we have done a good job.

Rodrigues: Would you say the NIH was unique in using
this approach to research in which nurses were more involved?

Baird: Yes, we were unique. Now, I think we see a lot
of copying. I think the extramural program has realized that this type
of research is a good area for a nurse. A nurse works well in such a position
because she can deal with diverse tasks. The extramural program now has
adopted this, and even some private, non NIH funded groups are using nurses
[for such research]. Ten years ago, they were using medical students or
doctors just out of medical school. Research was not the domain of a nurse.
The nurse now has very nicely fitted in, done a good job, and gained acceptance
in doing this kind of work.

Harden: Do you think that the acceptance of nurses
in research occurred now because society decided that women might have
heads on their shoulders and be able to do things like this, in contrast
to a couple of years ago when it was just assumed that they could not?

Baird: I think it all went together–there were many
more female physicians, and nurses were given more responsibility. I know
the NIH is a unique place because I formerly worked at Northern Virginia
Doctors Hospital. This was a doctor controlled hospital. The atmosphere
was incredibly different. Of course, this was ten or twelve years ago.
Then, when a doctor walked into the nurses' station, the nurse stood up.
The nurse gave the doctor her seat and she stood. When the doctor wanted
to make rounds, the nurse walked behind the doctor with the patient's
chart. They had a protocol for the way the nurses should behave that was
clearly out of the nineteenth century. I am still certain a hospital functions
this way in many parts of the country.

At the NIH and at some of the larger hospitals we have seen an incredible
transition in the past ten or fifteen years. For instance, nurses are
now no longer wearing their caps. Most nurses liked wearing the caps and
uniforms because it was distinctive. It separated them from the laboratory
technicians, and the floor washers. But what happened was that nurses
felt they were being identified in a demeaning way. They thought that
the cap was demeaning because it had its origin as a dust cap. Then, they
also felt that the uniform was demeaning. Many nurses have gotten away
from wearing the uniform. All of these changes have occurred. The uniform
is not being worn in many places, the four-year nursing degree program
is now being required by many hospitals. There were two kinds of nurses'
training, but diploma schools are now out of existence. In the nursing
field itself there have been many changes–the acceptance of nurses by
doctors, and then women's rights and so forth. This is a great time for
all this to occur. It has been a change for the better, there is a health
care team now.

Harden: Would you say, then, that professional protocol
means very little at the NIH, that the nurse does not have to waste energy
worrying about whether she is standing behind a doctor or in front, that
there is more of a partnership?

Baird: Yes. The other beautiful thing at the NIH is
that there is no profit motivation. When you work here you do not realize
that this can be a problem elsewhere. If you work in a community hospital,
or even in a medical center hospital that is doing research, there is
still some profit element. This requires the doctor and everyone else
to think twice about whether or not they want to do a test or how much
it costs. The minute you have to think about how much something costs,
it is going to affect the pureness, so to speak, of your job. You cannot
think only about the research, you have to think about the money. You
cannot think about what is the ideal approach because there are always
budgets and monetary things to worry about. Here, there is not this constant
profit issue. Without that pressure, doctors and nurses work more as colleagues,
as a team rather than as a hierarchy. You do not see the hierarchy at
the NIH. We all gather on Friday afternoon, and we have everybody there,
from the directors, Dr. Lane and Dr. Masur, to nutritionists, pharmacists,
case managers, nurses, and nursing assistants. Everybody is in that room
and everybody has input as to the care of the patient whom they are discussing
at that time. It is truly very team oriented, and there is no hierarchy
to worry about. That is very conducive to good work.